Module 5

Regulations and Standards

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In The Beginning ...

• On 8 November 1895, William Conrad Roentgen discovered the x-ray.

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The First X-Ray

On 22 December 1895, Mr. Roentgen made the first x-ray photograph (Mrs. Roentgen’s hand).

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The Aftermath

• On 1 January 1896, Roentgen announced his discovery to the world.

• 14 February 1896, four days after news of the discovery reached the U.S, x-rays were used to guide surgery in New York.

• In early 1896, the Italian military began using x-rays to diagnose and treat wounded soldiers

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At the same time ...

• In February 1896, Henri Becquerel discovered radioactivity.

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Recognizing the Hazards• Jan 1896: The first radiation burns were

reported• Nov 1896: Elihu Thompson intentionally

exposed his little finger to radiation over a period of a few days and then cautioned against over exposure “… or there may be cause for regret when too late.”

• Becquerel and Pierre Curie both suffered abdominal burns from carrying vials of radium in their vest pockets.

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Dose Limits

• 1977: ICRP (International Commisssion on Radiological Protection) recommends 5 rem/yr including internal exposures

• 1990: ICRP recommends 2 rem/yr averaged over 5 years with no single year exceeding 5 rem.

• 1994: NRC adopt 1977 recommendations.

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What Needs to be Regulated ?

• Byproduct Material• Source Material• Special Nuclear Material• Naturally occurring and Accelerator produced Radioactive Material

(NARM)• Ionizing Radiation Producing Devices

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Byproduct Material

• Any radioactive material (except special nuclear material) yielded in, or made radioactive by, exposure to the radiation incident to the process of producing or utilizing special nuclear material.

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Source Material

• Elemental Uranium or elemental Thorium or any combination of uranium and thorium in any physical or chemical form.

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Special Nuclear Material

• Plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235.

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NARM

• Naturally occurring or accelerator- produced radioactive material, such as radium, and not classified as source material.

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Ionizing Producing Devices

• Electronic devices that are capable of emitting ionizing radiation. Examples are linear accelerators, cyclotrons, radiofrequency generators that use cyclotrons or magnetrons, and other electron tubes that produce x-rays.

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Hierarchy of Standards

• Federal Laws and Regulations.• State Laws and Regulations• Accreditation Standards.• National and International

Consensus Standards and Guidance.

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Who Regulates What inOklahoma?

• NRC: Special Nuclear (more than 200 grams)

• State: Source, Byproduct, Special Nuclear (less than 200 grams) NARM and Radiation Producing Devices

• OSHA: Everything (sort of)• EPA: Disposal and Environmental Releases• DOT: Transportation• FDA: Radiation Producing Devices

(Performance)

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OK Environmental CodeOAC 252:410

• Oklahoma Department of Environmental Quality is the proponent.

• The OKDEQ issues specific licenses, for the receipt, possession, distribution, use, transportation, transfer, and disposal of radioactive material.

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OAC 252:410 (CONT.)

• OAC 252:410 : occupational dose limits, radiation dose limits for individual members of the public, surveys and monitoring, control of exposures from external sources in restricted areas, respiratory protection, storage and control, waste disposal, records, reports, and enforcement.

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Title 10 CFR

• a. Nuclear Regulatory Commission

(NRC) is the proponent.• b. Governs the use of special

nuclear material in excess of 200

grams.

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Title 21 CFR

• a. Public Health Service, Center for Devices and Radiological Health is the proponent.

• b. Governs standards and programs for cold cathode discharge tubes, x-ray inspections at airports, industrial x-ray equipment,

laser products, ultrasound devices, mercury vapor lamps and sun lamps .

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Title 29 CFR

• Occupational Safety and Health Administration (OSHA) is the proponent.

• Governs the use of all ionizing radiation to include alpha rays, beta rays, gamma rays, X-rays, neutrons, high-speed electrons, high speed protons, and other atomic particles.

• Part 1910.1096, Ionizing Radiation, includes requirements for dose limits, instructions to employees, posting requirements, and reports of overexposure.

• Memorandum of understanding with Nuclear Regulatory Commission.

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Title 49 CFR

• Transportation of Radioactive Materials.

• Regulated, determine methodology with RSO before offsite transportation.

• Radioactive Waste is transported off-site by licensed contractors.

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RADIATION PROTECTION GOALS

• LIMIT PROBABILITY OF RADIATION BIOEFFECTS

• DEVELOP ACCEPTABLE RISK WITH DERIVED BENEFITS

• PROTECT HUMAN KIND AND ITS ENVIRONMENT

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RADIATION PROTECTION OBJECTIVES

• PREVENTION OF NON-STOCHASTIC DISEASE

• SEVERITY VARIES WITH MAGNITUDE OF DOSE• HEALTH EFFECTS HAVE A THRESHOLD DOSE• EXAMPLES: CATARACTS, IMPAIRMENT OF

FERTILITY

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RADIATION PROTECTION OBJECTIVES (cont.)

• LIMIT RISK OFSTOCHASTICHEALTH EFFECTS

• SEVERITY INDEPENDENT OF DOSE (BOTH SOMATIC AND GENETIC)

• EXAMPLES: LEUKEMIA, MALGNANT TUMORS

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RADIATION PROTECTION PHILOSOPHY

• BENEFITS GREATER THAN RISKS INVOLVED

• RADIATION DOSES AS LOW AS REASONABLY ACHIEVABLE (ALARA)

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RADIATION RISK IN PERSPECTIVE

• RADIOGENIC HEALTH EFFECTS HAVE NOT BEEN OBSERVED BELOW DOSES OF 10 REM

• LIMITATION OF QUANTITATIVE RISK ASSESSMENTS TO DOSES AT OR ABOVE 5 REM PER YEAR OR 10 REM LIFETIME

• USE OF QUALITATIVE RISK ASSESSMENT BELOW 5 REM PER YEAR - MANAGEMENT OF ALARA IN RADIATION PROTECTION

• Source: Health Physics Society Position Statements - 1999

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Notice to Employees

It is a requirement of the Oklahoma Department of Environmental Quality that Notice to Employees from DEQ form # 410-3 be posted.

In essence it informs employees of their rights and where they can report concerns. Also it informs the employees where they can examine the license and the regulations.